FEATURED EDITORIAL

GUEST CONTRIBUTORS

  • Cheating In The Lab: 3 Data Integrity Pitfalls To Avoid In Laboratory Operations
    Cheating In The Lab: 3 Data Integrity Pitfalls To Avoid In Laboratory Operations

    FDA inspectors continue to observe CGMP violations involving data integrity during CGMP inspections of laboratory operations. At least 20 percent of all warning letters issued by the CDER Office of Manufacturing Quality in 2017 included explicit observations by inspectors of blatant data integrity violations in laboratory operations. While there has been an increase in warning letters issued to firms in China and India for flagrant data integrity violations, firms in the United States, Europe, and Japan have also been cited with similar violations.

  • The Global CDMO Model: Value Creation Is Not Just A Matter Of Integrating The Pieces
    The Global CDMO Model: Value Creation Is Not Just A Matter Of Integrating The Pieces

    Larger CDMOs are broadening their scale and services to fill strategic gaps by building a mosaic comprised of smaller, focused-service providersThis trend is effectively increasing the size and scope of the large global end-to-end CDMOs, while reducing the number of small and midsize service providers. Has a void has been created?

  • Identifying Outliers In Process Data Using Visual And Analytical Techniques
    Identifying Outliers In Process Data Using Visual And Analytical Techniques

    Identifying outlier data points using visual and analytical techniques is especially important for proper process validation, control, and monitoring in the FDA regulated industries. Additionally, properly identifying outliers can assist FDA regulated companies with the proper establishment of trending and excursion limits for complaint and nonconformance management, and other aspects such as environmental monitoring, which can trigger investigations or initiate the formal corrective and preventive action (CAPA) process.

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PHARMA OUTSOURCING WHITE PAPERS

Scalable Strategies For Parenteral Dosage Form Selection Scalable Strategies For Parenteral Dosage Form Selection

Understand the strategies which can be employed at the different stages of development when choosing parenteral dosage forms.

 

Multiplexing: Managing Risk With Proven, Single-Use Solutions Multiplexing: Managing Risk With Proven, Single-Use Solutions

With many uncertainties when introducing a new drug to market, seeking manufacturing flexibility to accommodate diverse demands and production needs is key.

Fundamentals Of Spray-Dried Dispersion Technology

A common problem statement in the pharmaceutical industry is low oral bioavailability of drug candidates with poor aqueous solubility.

The Race to Phase III: A Cautionary Tale of Scalability

Follow the paths of two companies as they learn how a science-led, risk-based development approach yields a more successful outcome in the long run.

Liquid Filling In Hard Gelatin Capsules — Preliminary Steps
For more than 20 years, the liquid or semi-solid filling of hard gelatin capsules have been routinely performed by the pharmaceutical industry. Among the various aspects of this technique, the selection of the excipients or fills to be used remains a key step of the development process. Submitted by Capsugel
Securing The Global Pharmaceutical Supply Chain Against The Threat Of Counterfeit Drugs

According to the World Health Organization (WHO), the prevalence of spurious, falsely-labelled, falsified, or counterfeit medicines, or SFFC medicines as they are known — medicines that are deliberately and fraudulently produced, packaged and/or mislabeled — is a growing trend worldwide which threatens both patient safety as well as public confidence in the health systems and regulatory bodies designed to provide oversight and control.

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PHARMA OUTSOURCING APP NOTES & CASE STUDIES

Two-Step Purification Of Monoclonal IgG1 From CHO Cell Culture Supernatant

The increasing demand for monoclonal antibodies (MAb) as biopharmaceuticals has promoted the development of cell cultures with increased expression levels. As a consequence, the demand for more effi cient purifi cation processes has increased. This application note describes a two-step process for MAb purifi cation based on MabSelect SuRe™ and Capto™ adhere, a strong multimodal anion exchanger. By GE Healthcare

Purification Of An N-Terminal Histidine-Tagged Protein Using ÄKTA™ start

ÄKTA start eliminates the hassles of manual protein purification handling, such as loading large sample volumes and continually monitoring UV readings, and can give you consistency of yield and purity. Madhu demonstrates how ÄKTA start aided him in purifying a recombinant N-terminal histidine-tagged protein.

A Rapid Filtration Method For Harvesting Mammalian Cell Culture Grown In Cellbag Bioreactors

Disposable bioreactors have gained widespread acceptance in cell culture applications because they provide a flexible resource for multiproduct facilities and speed the production of biomolecules.

Efficient And Reliable Protein Purification

Biopharmaceutical manufacturer’s goals are to develop a process that will deliver material for clinical trials quickly and smoothly, achieve success in these trials, and scale up to commercial manufacturing. Traditionally, column packing has been considered a bottleneck. Suboptimal packing is not only time-consuming, but can result in poor performance. By eliminating these two concerns, you can focus on the core process.

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ABOUT US

Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.

About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

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INDUSTRY INSIGHTS

  • Solving The OOS Problem With Continuous Manufacturing
    Solving The OOS Problem With Continuous Manufacturing

    With continuous manufacturing, it is possible to monitor product quality continuously, and make adjustments in real time to keep the product in spec.

  • Implications Of Inaccurate Forecasting On Biologics Manufacturing
    Implications Of Inaccurate Forecasting On Biologics Manufacturing

    Inaccurate demand forecasts can have significant implications for companies developing biologics. And, it is increasingly difficult to locate capacity to respond to demand changes.

  • Choosing The Right Single-Use Bioreactor Platform
    Choosing The Right Single-Use Bioreactor Platform

    When selecting a bioreactor, you can choose stainless steel or single-use technologies, depending on your biomanufacturing requirements. The bioreactor is a key component of your bioprocessing workflow and should be regarded as a strategic asset. It is important that this core technology is carefully chosen, specified, designed, and supported, both now and in the future.

  • Determining The Right Type Of Biomanufacturing Capacity
    Determining The Right Type Of Biomanufacturing Capacity

    In selecting a biomanufacturing platform, it's necessary to properly understand what the industry needs are and what aspects of the drug development and clinical pathway you intend to support with your new manufacturing capacity. Having a rigorous selection and assessment criteria will ensure you make the right decision.

  • Built To Fail: How Today’s Manufacturing Options Leave Pharma At Risk
    Built To Fail: How Today’s Manufacturing Options Leave Pharma At Risk

    Though pharma companies do their best to understand the environment, it can be very difficult to predict demand, and the consequences of incorrect forecasts can be very costly in a number of ways. 

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OUTSOURCING EVENTS

CAPA and Root Cause Analysis Essentials Post ICH GCP E6 (R2) Addendum January 22, 2018
11am-12:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Sterility Failure Investigations – A Step-by-Step Process for Success January 24, 2018
1pm-2:30pm EST, Online Training)
Price:  $299 - Includes Bonus Handouts!
The New Medical Device Reporting (MDR) Guidance – An Easily Digestible Compliance Breakdown January 25, 2018
1pm-2:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
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